Plus Ça Change…Nothing Changes With a New Year!

Article

Despite all the hopes and wishes for a better new year, the start to 2021 in Europe is proving to be grimly similar to the end of 2020.

The chaotic start to 2021 in Europe is proving to be depressingly similar to the end of 2020, despite all the hopes and wishes for a better new year expressed in countless greetings over the holiday festivities.

Monday, the first day back at work, saw EU officials again defending their COVID vaccine strategy in the face of recriminations and accusations of delay, while the—now entirely Brexited—UK was flaunting the first administrations of the AstraZeneca/Oxford vaccine to which it gave emergency-use approval as the old year ended, to run in parallel with its earlier approval for the Pfizer/BioNTech Comirnaty.

National authorities around Europe have been complaining that despite all the EU's claims of a successfully coordinated approach, with its much-hyped "vaccination days" at the end of December to launch Comirnaty, supplies of the product have been too little and too late. At the same time, patient groups and doctors have been grumbling that vaccination is not happening fast enough even with the limited supplies that are available. And the EU authorities are passing the blame straight back to the member states: they agreed last July to the EU's "rigorous" approach of requiring marketing authorizations from the European Medicines Agency, and they were themselves responsible for organizing their national vaccine roll-outs, on which the EU had issued recommendations as far back as October. In addition, officials have been pointing out, it has always been understood that there could be no more than a low-volume start to vaccination in January, since production was never envisaged to attain scale until the spring.

Much of the resentment is colored by the UK government's continued implication that freeing itself from what it views as the shackles of EU regulation has allowed it to move faster. The UK medicines agency took advantage of today's return to work to announce that it would be providing a new fast-track approval system for innovative medicines, for a "new era in medicines approvals" in the UK. And it is proudly boasting that it has secured access to nearly 400 million doses of vaccine—which compares favorably, on paper at least, with the EU's plans.

There is therefore some detectable schadenfreude in Europe right now as the UK's failure to grapple effectively with the coronavirus epidemic sees cases soar to new record heights, despite its vaccine acquisitions. A leading French health official today described the UK as being in a "catastrophic situation". The UK's much-vaunted reaffirmation of its "sovereignty" now that Brexit is fully and finally in force since the first day of January is indeed looking a little more like isolation than independence, as the fragility of the vital trade route across the Channel was so vividly demonstrated by 20-mile queues of freight trucks in the run-up to Christmas, and by the refusal by EU immigration authorities to allow non-essential entry to UK citizens now that Brexit has ended their automatic travel rights in Europe. EU-based retailers and logistics operations including Fedex and TNT are warning of additional charges to UK customers because of Brexit-induced changes to customs and taxation.

On Wednesday, after disappointing expectations today, EMA is expected to issue a conditional marketing authorisation for the Moderna vaccine, although it does not anticipate any authorisation for the AZ/Oxford product until after January. EU officials are meanwhile negotiating for additional supplies of Comirnaty, and confronting national squabbles over allocations. As an EU official remarked today, "There is a long and bumpy road ahead."

© 2024 MJH Life Sciences

All rights reserved.